Senior Informed Consent Specialist

ICON · Blue Bell +1 more

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Clinical OperationsFull-timeCompany career page

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Role summary

ICON seeks a Senior Informed Consent Specialist to lead development and oversight of informed consent strategies and documents for complex, global clinical studies. The role involves ensuring participant-facing materials meet ethical, compliance, and comprehension standards while mentoring junior specialists.

What they're looking for

Bachelor's degree in scientific discipline or healthcare-related field
Extensive clinical research, regulatory affairs, ethics, or informed consent experience
In-depth knowledge of GCP, ethical principles, and global regulatory expectations
Exceptional writing and editing skills for patient-friendly documentation
Strong stakeholder management experience with sponsors, IRBs/ECs, and cross-functional teams
Proven ability to manage multiple complex studies and deadlines with high accuracy

What you'll be doing

Lead creation, review, and optimisation of global and country-specific informed consent forms
Advise study teams on informed consent strategies including readability and cultural considerations
Oversee translation, localisation, and version control processes across regions
Interact with sponsors, ethics committees, and regulatory authorities on consent-related matters
Develop guidance, templates, and training materials to standardise informed consent practices

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Date posted1 day ago

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